The Effect of Solifenacin on Post Void Dribbling in Women

NCT ID: NCT01470001

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-09-30

Brief Summary

This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.

Detailed Description

This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in post void dribbling episodes.

2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.

We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Conditions

Post-micturition Incontinence; Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

solifenacin

patients in this arm will receive drug

Group Type: ACTIVE_COMPARATOR

solifenacin

Intervention Type: DRUG

patient will receive solifenacin 5mg daily or placebo daily

placebo

patients is this arm will receive placebo

Group Type: PLACEBO_COMPARATOR

solifenacin

Intervention Type: DRUG

patient will receive solifenacin 5mg daily or placebo daily

Interventions

solifenacin

patient will receive solifenacin 5mg daily or placebo daily

Intervention Type: DRUG

Other Intervention Names

vesicare

Eligibility Criteria

Inclusion Criteria

1. Women between the ages of 18 and 89

2. Incontinence in the form of post void dribbling that occurs at least twice weekly.

Exclusion Criteria

1. Severe renal or hepatic disease.

2. Active urinary tract infection.

3. Glaucoma.

4. Stress incontinence as the only incontinence symptom

5. Urge incontinence as the only incontinence symptom

6. Chronic severe constipation.

7. History of bladder cancer.

8. Known or suspected hypersensitivity to anticholinergics.

9. Any clinical condition that would not allow safe completion of the study.

10. Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.

11. Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.

12. Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tova S Ablove, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2011-0513

Identifier Type: -

Identifier Source: org_study_id